Description
This detailed volume collects numerous methods and protocols related to different aspects of stability programs that are followed in pharmaceutical development laboratories. Implementation of a successful stability program, vital in preventing product failures and recalls, requires critical and logical thinking that goes beyond the regular documented protocols and methods, so the experiences of the book’s internationally-based expert contributors fill the chapters with practical guidance. As a volume in the Methods in Pharmacology and Toxicology series, this book presents the kind of real-world advice that is essential for advancing laboratory research. Authoritative and thorough, Methods for Stability Testing of Pharmaceuticals serves as a valuable addition to the existing armamentarium of resources available to stability testing personnel in research and industry. 1. Regulatory Guidelines on Stability Testing and Trending of Requirements Dilip Kumar Singh, Saranjit Singh, and Sanjay Bajaj 2. The Stability Dossier: Common Deficiencies and Ways to Improve Paul Marshall 3. In Silico Drug Degradation Prediction Mohammed A. Ali, Rachel Hemingway, and Martin A. Ott 4. Forced Degradation and Long-Term Stability Testing for Oral Drug Products: A Practical Approach Markus Zimmer 5. A Model Approach for Developing Stability-Indicating Analytical Methods Peter Persich, Mario Hellings, Shalu Jhajra, Pradeep Phalke, and Koen Vanhoutte 6. Protocols for Characterization of Degradation Products with Special Emphasis on Mutagenic Degradation Impurities Steven Hostyn, Peter Persich, Shalu Jhajra, and Koen Vanhoutte 7. Stability Studies: Facility and Systems Ashish Gogia and Sumathi V. Rao 8. User Requirements & Implementation of a Risk-Based, Compliant Stability Management System Based on the FDA New Guidance on DATA Integrity Susan Cleary, Parsa Famili, and Pedro Jorge 9. Stability Considerations in the Life Cycle of Generic Products Sanjay Bajaj, Srinivasan Rajamani, and Mona Gogia 10. Predictive Stability Testing Utilizing Accelerated Stability Assessment Program (ASAP) Studies Helen Williams 11. Statistical Methods and Approaches to Avoid Stability Failures of Drug Product During Shelf-Life Suresh Kumar BV, Priyanka Kulshrestha, and Sandeep Shiromani 12. Estimation of Stability Based on Monitoring of Shipment and Storage Manuel Zahn 13. Stability Testing Parameters and Issues for Nanotechnology-Based Drug Products Kamla Pathak and Satyanarayan Pattnaik 14. Stability Testing Issues and Test Parameters for Herbal Medicinal Products Gulshan Bansal, Jasmeen Kaur, Nancy Suthar, Sarabjeet Kaur, and Rahul Singh Negi 15. Stability Testing Considerations for Biologicals and Biotechnology Products Christine P. Chan
